Trial record 2 of 229 for:    Open Studies | "Labor, Obstetric"

Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01317225
First received: March 16, 2011
Last updated: June 30, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.


Condition Intervention Phase
Preterm Birth
Obstetric Labor, Premature
Drug: 17 α hydroxyprogesterone caproate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 37 weeks of gestation in patients with a previous episode of threatened preterm labor. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 35 weeks of gestation in patients with a previous episode of threatened preterm labor. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 32 weeks of gestation in patients with a previous episode of threatened preterm labor. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progesterone Drug: 17 α hydroxyprogesterone caproate
250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
Other Name: 17 α hydroxyprogesterone caproate
Placebo Comparator: Placebo Drug: Placebo
250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.
Other Name: Saline solution

Detailed Description:

Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women between 26 and 34 weeks of gestation.
  • Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.

Exclusion Criteria:

  • Multiple gestations.
  • Maternal pathologies in which preterm termination of pregnancy is required.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317225

Contacts
Contact: Osvaldo A Reyes, MD (Gyn/Ob) 011(507)65655041 oreyesmaternidad@gmail.com
Contact: Rodrigo Velarde, MD (Gyn/Ob) 011(507)66159954 revelarde_14@yahoo.es

Locations
Panama
Saint Thomas Maternity Hospital Recruiting
Panama, Panama
Contact: Osvaldo A Reyes, MD (Gyn/Ob)    011(507)65655041    oreyesmaternidad@gmail.com   
Contact: Rodrigo Velarde, MD (Gyn/Ob)    011(507)66159954    revelarde_14@yahoo.es   
Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob)         
Principal Investigator: Rodrigo Velarde, MD (Gyn/Ob)         
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob) Saint Thomas Maternity Hospital
Principal Investigator: Rodrigo Velarde, MD (Gyn/Ob) Saint Thomas Maternity Hospital
  More Information

No publications provided

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01317225     History of Changes
Other Study ID Numbers: MHST2011-01
Study First Received: March 16, 2011
Last Updated: June 30, 2013
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Progesterone
Obstetric labor, premature
Short cervix

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth
Pregnancy Complications
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on July 29, 2014